The nature and the purpose of the ECRIN Data Centre Certification Programme are summarised, and a very brief description is given of the underlying standards (129 in total, divided into 19 separate lists). The certification activity performed so far is described. In a pilot phase 2 centres were certified in 2012. Calls in 2014 and 2015 resulted in a further 8 certified centres, with 2 certifications still in progress, and the 2016 call has generated several additional applications. The impact and benefits of the programme are listed, divided into a) the effects of the introduction of the standards, b) the effects of the certification programme in general, and c) the effects of the certification programme on individual units. The discussion emphasises the generally positive impact of the programme so far but stresses the need to better clarify the perspective and role of the programme.

Chair of ECRIN Independent Certification Board and Network Committee ECRIN Düsseldorf Germany

Director General of ECRIN ECRIN Paris France

Member of ECRIN Independent Certification Board Cardiovascular Research Clinical Drug Evaluation Mario Negri Institute for Pharmacological Research Milano Italy

Member of ECRIN Independent Certification Board Centre d'Investigation Clinique Epidémiologie Clinique Bordeaux France

Member of ECRIN Independent Certification Board Department of Clinical Medicine Odense University Hospital Odense Denmark

Member of ECRIN Independent Certification Board Medical Statistics Core Facility IDIBAPS Hospital Clinic Barcelona Barcelona Spain

Member of ECRIN Independent Certification Board Serviços Partilhados do Ministério da Saúde Lisboa Portugal

Member of ECRIN Independent Certification Board Shared Services of Ministry of Health Lisboa Portugal

Member of ECRIN Independent Certification Board St Ann's University Hospital Brno Czechia

Scientific Secretary of ECRIN Independent Certification Board ECRIN Surrey UK

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European survey on national harmonization in clinical research